Clinical trial Recruiting at 1 site Observational

Long-term outcomes of primary biliary cholangitis in China

Official title: A Multi-center Prospective-retrospective Study of the Clinical Characteristics, Biochemical Response, and Long-term Outcomes in Patients With Primary Biliary Cholangitis

Run by Beijing Friendship Hospital · NCT07149675 · Data updated 2026-11-12

This project will follow about 4,000 people in China with primary biliary cholangitis to see how symptoms, disease stage, and treatments affect long-term survival.

More Primary Biliary Cholangitis (PBC) trials

Quick facts

Study typeObservational
SexAll
Enrollment4000 (estimated)
SponsorBeijing Friendship Hospital
Academic / other
Locations1 site (Beijing, Select A State Or Province)
StatusRecruiting
StartedMay 18, 2025
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedSeptember 2, 2025
Trial IDNCT07149675 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with a confirmed diagnosis of PBC who can provide informed consent and adhere to follow-up, and who do not have the specified exclusionary liver diseases or severe comorbidities, are ideal candidates.

Probably not a fit

Patients with concurrent chronic hepatitis B or C, autoimmune hepatitis, drug-induced liver injury, other disqualifying liver diseases, active malignancy, severe organ failure, or incomplete baseline records are unlikely to benefit from the study results.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective-prospective multicenter cohort enrolling roughly 4,000 PBC patients from ten centers across China, led by Beijing Friendship Hospital. Investigators will collect baseline clinical and laboratory data and perform longitudinal follow-up to record survival, disease progression, and treatment changes. Analyses will examine the effects of symptoms, disease stage, biochemical response to ursodeoxycholic acid (UDCA), and use of second-line therapies on long-term outcomes. The study excludes patients with other chronic liver diseases, active malignancy, or severe comorbidities and aims to generate prognostic models tailored to the Chinese population.

Why it matters

Potential benefit: If successful, the findings could help doctors better predict prognosis and tailor treatment plans for people in China with PBC.

How similar studies have gone: Several single-center cohorts in China have reported prognostic factors and shown that biochemical response to UDCA predicts survival, but large multicenter outcome data are still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis consistent with PBC.
* Willingness to participate, with informed consent obtained from the patient or legal representative (if the patient is deceased or cognitively impaired), and ability to adhere to follow-up.

Exclusion Criteria:

* Co-existing chronic hepatitis B or C, drug-induced liver injury, autoimmune hepatitis, primary sclerosing cholangitis, or hereditary/metabolic liver diseases.
* Co-existingMalignancy or severe cardiac, pulmonary, renal, cerebral, or hematologic disorders expected to substantially shorten life expectancy.
* Incomplete baseline medical records or laboratory data.

Where it's running

  • Liver Research Center, Beijing Friendship Hospital, Capital Medical University
    Beijing, Select A State Or Province, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.